标准摘要
[中文适用范围]： 本国际标准适用于医疗电气设备 (ME设备) 和医疗电气系统 (ME系统) 的基本安全和主要性能。本 collateral 标准规定了作为生理闭环控制系统 (PCLCS) 一部分的生理闭环控制器 (PCLC) 的开发要求 (分析、设计、验证和验证)，用于在 ME设备和 ME系统中控制至少一个患者变量 (即生理变量) 以控制生理变量。注意：生理变量可以是身体化学物 (例如电解质、血糖)、物理特性 (例如患者体温、电生理、血流动力学) 或药物浓度。示例：患者变量可以是身体化学物的测量值 (例如电解质或血糖值)、物理特性 (例如体温、电生理特性、血流动力学量) 或药物浓度。本 collateral 标准适用于各种类型的 PCLC，例如线性和非线性、自适应、模糊、神经网络。本 collateral 标准不规定：额外的机械要求；或额外的电气要求。本 collateral 标准适用于闭环控制器 (见图1)，该控制器设定控制器输出变量，以便通过将其与参考变量相关联来调整 (即改变或维持) 测量的生理变量。使用未从患者测量的反馈来维持物理或化学变量的闭环控制器，不在本标准范围内。 [外文原描述]： IEC 60601-1-10:2007+A1:2013+A2:2020 Specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems to control a physiologic variable. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard applies to a closed-loop controller that sets the controller output variable in order to adjust (i.e., change or maintain) the measured physiologic variable by relating it to the reference variable. This consolidated version consists of the first edition (2007), its amendment 1 (2013) and its amendment 2 (2020). Therefore, no need to order amendments in addition to this publication.
英文名称Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers